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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL133521 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of the study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile phone-based) program to improve physical activity levels and quality dietary intake among Hispanic parent-adolescent dyads.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Juntos Intervention Condition | Experimental | Parent-adolescent dyads randomized to the Healthy Juntos intervention condition will access a program that includes didactic, behavioral, and positive parenting content from their smartphones for 8 weeks. |
|
| Control Group | No Intervention | This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites which they may access at their discretion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Juntos | Behavioral | Parent-adolescent dyads will log in to a secured website for a total of eight weeks. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support ("supportive accountability") will be provided. Specifically, each family will be assigned a "coach" who will use video conferencing software to engage in weekly 15-30 minute sessions regarding the family's progress throughout the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adolescents Physical Activity | Adolescents will self-report physical activity using the Youth Activity Profile. | Baseline, up to 2 months |
| Change in Adolescent Sedentary Behavior | Adolescents will self-report sedentary behavior using the Youth Activity Profile. | Baseline, 2 months |
| Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables) | Adolescents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute. | Baseline, 2 months |
| Change in Adolescents Dietary Intake (Sugar) | Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars. | Baseline, up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parent Physical Activity. | Parents will self-report physical activity using the International Physical Activity Questionnaire. | Baseline, up to 2 months |
| Change Parent Sedentary Behavior |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara M St George, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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50 parent-adolescent dyads were enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Juntos Intervention Condition | Parent-adolescent dyads randomized to the Healthy Juntos intervention condition will access a program that includes didactic, behavioral, and positive parenting content from their smartphones for 8 weeks. Healthy Juntos: Parent-adolescent dyads will log in to a secured website for a total of eight weeks. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support ("supportive accountability") will be provided. Specifically, each family will be assigned a "coach" who will use video conferencing software to engage in weekly 15-30 minute sessions regarding the family's progress throughout the intervention period. |
| FG001 | Control Group | This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites which they may access at their discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Juntos Intervention Condition | Parent-adolescent dyads randomized to the Healthy Juntos intervention condition will access a program that includes didactic, behavioral, and positive parenting content from their smartphones for 8 weeks. Healthy Juntos: Parent-adolescent dyads will log in to a secured website for a total of eight weeks. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support ("supportive accountability") will be provided. Specifically, each family will be assigned a "coach" who will use video conferencing software to engage in weekly 15-30 minute sessions regarding the family's progress throughout the intervention period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | A total of 50 participants were included in each arm. Given the nature of the intervention being dyadic we have included 25 parents and 25 adolescents for each group to provide each group's age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Adolescents Physical Activity | Adolescents will self-report physical activity using the Youth Activity Profile. | Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off of participants. | Posted | Mean | Standard Deviation | minutes/day | Baseline, up to 2 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Juntos Intervention Condition | Parent-adolescent dyads randomized to the Healthy Juntos intervention condition will access a program that includes didactic, behavioral, and positive parenting content from their smartphones for 8 weeks. Healthy Juntos: Parent-adolescent dyads will log in to a secured website for a total of eight weeks. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support ("supportive accountability") will be provided. Specifically, each family will be assigned a "coach" who will use video conferencing software to engage in weekly 15-30 minute sessions regarding the family's progress throughout the intervention period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sara St George | University of Miami Miller School of Medicine | 305-243-0726 | s.stgeorge@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2021 | Apr 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 8, 2022 | May 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire
| Baseline, up to 2 months |
| Change in Parents Dietary Intake (i.e., Fruits/Vegetables) | Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute. | Baseline, up to 2 months |
| Change in Parents Dietary Intake (Sugar) | Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars. | Baseline, up to 2 months |
| BG001 | Control Group | This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites which they may access at their discretion. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Physical Activity | Results are displayed separately for parents and adolescents. | Mean | Standard Deviation | Minutes/day |
|
| Fruit and Vegetable Intake | Results are displayed by separately for parents and adolescents. | Mean | Standard Deviation | cups/day |
|
| Adolescents Sedentary Behavior Out-of-school | Results are displayed separately for parents and adolescents. | Mean | Standard Deviation | Minutes/day |
|
| Parents Sedentary Behavior | Results are displayed separately for parents and adolescents | Mean | Standard Deviation | Sitting hours/day |
|
| OG001 | Control Group | This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites which they may access at their discretion. |
|
|
| Primary | Change in Adolescent Sedentary Behavior | Adolescents will self-report sedentary behavior using the Youth Activity Profile. | Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off. | Posted | Mean | Standard Deviation | minutes/day | Baseline, 2 months |
|
|
|
| Primary | Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables) | Adolescents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute. | Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off from baseline to T2 assessment. | Posted | Mean | Standard Deviation | cups/day | Baseline, 2 months |
|
|
|
| Primary | Change in Adolescents Dietary Intake (Sugar) | Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars. | Difference at control group is due to lost of follow-up. | Posted | Mean | Standard Deviation | Teaspoon per day | Baseline, up to 2 months |
|
|
|
| Secondary | Change in Parent Physical Activity. | Parents will self-report physical activity using the International Physical Activity Questionnaire. | Posted | Mean | Standard Deviation | minutes/day | Baseline, up to 2 months |
|
|
|
| Secondary | Change Parent Sedentary Behavior | Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire | Posted | Mean | Standard Deviation | sitting hours/day | Baseline, up to 2 months |
|
|
|
| Secondary | Change in Parents Dietary Intake (i.e., Fruits/Vegetables) | Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute. | Difference is total numbers due to drop-off. | Posted | Mean | Standard Deviation | cups/day | Baseline, up to 2 months |
|
|
|
| Secondary | Change in Parents Dietary Intake (Sugar) | Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars. | Posted | Mean | Standard Deviation | teaspoon/day | Baseline, up to 2 months |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control Group | This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites which they may access at their discretion. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Female |
|
| Unknown or Not Reported |
|
| Fruit intake |
|
|
| Fruit intake |
|
|